NCT01245088撤回1 期
A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Biologic effect on inflammation
研究概览
简要总结
Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonic or ileocolonic CD diagnosed for at least 3 months.
- •Active CD, defined as a Crohn's Disease Activity Index (CDAI; Appendix A) [Best 1976] of greater than 200 but less than 320 at the time entry into the study.
- •Age > 18 years.
- •Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment.
- •Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment.
- •Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment.
- •Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment.
- •Patient on biologic therapy with infliximab, adalimumab, or certolizumab must be on stable therapy for 12 weeks prior to enrollment
- •Patient must sign informed consent.
排除标准
- •Patients with only small bowel CD, fistulizing CD, or gastroduodenal CD without colonic involvement.
- •Patients with known ulcerative colitis.
- •Patients expected to require surgery within 30 days for complications of CD.
- •Patients with CD and an intraabdominal abscess.
- •Patients requiring continuous antibiotics; antibiotics may be taken up to the point of enrollment into the study.
- •Patients with severe cardiac, pulmonary, or renal disease.
- •Patients with a h/o malignancy other than resected basal cell carcinoma of the skin
- •Patients who have participated in another clinical research study in the past 8 weeks.
- •Patients who are pregnant.
研究组 & 干预措施
chondroitin sulfate
Experimental
400 mg (one table) TID
干预措施: chondroitin sulfate (Drug)
结局指标
主要结局
Biologic effect on inflammation
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Jeffry A. Katz
Associate Professor of Medicine
University Hospitals Cleveland Medical Center
研究点 (1)
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